Point-of-Care Ultrasonography for Intussusception

Point-of-Care Ultrasonography for Intussusception: A Randomized Noninferiority Trial

Pediatric emergency medicine (PEM) physicians are increasingly utilizing point-of-care ultrasound (POCUS). There is currently limited data regarding POCUS evaluation for intussusception in pediatric patients. To better understand the role of POCUS for identification of intussusception, the investigators plan to conduct a randomized, noninferiority study comparing POCUS and radiology-performed ultrasound (RADUS), utilizing experienced sonographers across multiple institutions.

Study Overview

• Status: Completed
• Conditions: Emergencies; Intussusception
• Intervention / Treatment: Diagnostic test: Point-of-care ultrasound prior to radiology ultrasound; Diagnostic test: Radiology-performed ultrasound

Detailed Description

Intussusception is the most common causes of bowel obstruction among children less than 6 years of age. Limited abdominal ultrasonography is recommended as the initial screening study, prior to enema or surgical reduction for definitive treatment. Although ultrasonography is typically performed by ultrasound technicians and interpreted by radiologists, recently published guidelines include identification of intussusception as an adjunct POCUS application for emergency physicians to use at the bedside.

Two previous studies have investigated POCUS use by PEM physicians for the diagnosis of intussusception, both of which largely incorporated novice sonographers with limited training in bowel ultrasonography. Only one previous prospective investigation has investigated POCUS for the identification of intussusception, with a reported POCUS sensitivity of 85% (95% confidence interval 54-97%) and specificity of 97% (95% confidence interval 89-99%) when compared to RADUS. In contrast, the sensitivity and specificity of RADUS have been reported to range from 98-100% and 88-98%, respectively, when compared to enema or surgical reduction. Given the limited evidence available, it remains unclear whether POCUS performs similar to RADUS in terms of diagnostic accuracy.

The primary aim of this study is to determine whether POCUS is noninferior to RADUS for the detection of intussusception. The secondary aims are to determine whether rates of serious complications or resource utilization measures differ among patients randomly assigned to receive POCUS prior to RADUS or RADUS alone. The investigators hypothesize that diagnostic accuracy, expressed as sensitivity and specificity, is similar for POCUS and RADUS, and that rates of serious complications and resource utilization measures do not differ across groups.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children 3 months through 6 years of age;
• Clinical suspicion for intussusception per treating emergency physician.

Exclusion Criteria:

• Need for critical care resuscitation (intubation or vasopressors);
• Emergent situation where the treating provider determines that POCUS prior to RADUS may interfere with clinical care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Point-of-care ultrasound prior to radiology ultrasound	Diagnostic test: Point-of-care ultrasound prior to radiology ultrasound; Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound
Active Comparator: Radiology-performed ultrasound	Diagnostic test: Radiology-performed ultrasound; Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity	2 years from start of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of recurrent intussusception	The number of patients with recurrent intussusception in each study arm	2 years from start of enrollment
Rate of peritonitis	The number of patients with peritonitis in each study arm	2 years from start of enrollment
Rate of bowel perforation	The number of patients with bowel perforation in each study arm	2 years from start of enrollment
Rate of intestinal obstruction	The number of patients with intestinal obstruction in each study arm	2 years from start of enrollment
Rate of shock	The number of patients with shock in each study arm	2 years from start of enrollment
Rate of death	The number of deaths in each study arm	2 years from start of enrollment
Emergency Department length of stay		2 years from start of enrollment
Hospital length of stay (for patients admitted to the hospital)		2 years from start of enrollment
Emergency Department laboratory investigations	The total number of laboratory investigations obtained per patient	2 years from start of enrollment
Radiology studies	The total number of radiology studies obtained per patient	2 years after start of enrollment
Emergency Department return visit at 3 days	Return ED visit 3 days after index ED visit	3 days after the index ED visit
Emergency Department return visit at 7 days	Return ED visit 7 days after index ED visit	7 days after the index ED visit
Differentiation of ileocolic and ileoileal intussusception, measured in centimeters	Ileocolic intussusception will be identified by a maximal cross-sectional diameter of greater than or equal to 2.5 cm; and ileoileal intussusception will be considered less than 2.5 cm in maximal cross-sectional diameter	2 years from start of enrollment

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota

Publications and helpful links

General Publications

• Ahn S, Park SH, Lee KH. How to demonstrate similarity by using noninferiority and equivalence statistical testing in radiology research. Radiology. 2013 May;267(2):328-38. doi: 10.1148/radiol.12120725.
• Waseem M, Rosenberg HK. Intussusception. Pediatr Emerg Care. 2008 Nov;24(11):793-800. doi: 10.1097/PEC.0b013e31818c2a3e.
• Hryhorczuk AL, Strouse PJ. Validation of US as a first-line diagnostic test for assessment of pediatric ileocolic intussusception. Pediatr Radiol. 2009 Oct;39(10):1075-9. doi: 10.1007/s00247-009-1353-z. Epub 2009 Aug 6.
• Daneman A, Navarro O. Intussusception. Part 1: a review of diagnostic approaches. Pediatr Radiol. 2003 Feb;33(2):79-85. doi: 10.1007/s00247-002-0832-2. Epub 2002 Nov 19.
• Daneman A, Navarro O. Intussusception. Part 2: An update on the evolution of management. Pediatr Radiol. 2004 Feb;34(2):97-108; quiz 187. doi: 10.1007/s00247-003-1082-7. Epub 2003 Nov 21.
• American College of Emergency Physicians. Emergency ultrasound guidelines. Ann Emerg Med. 2009 Apr;53(4):550-70. doi: 10.1016/j.annemergmed.2008.12.013. No abstract available.
• Vieira RL, Hsu D, Nagler J, Chen L, Gallagher R, Levy JA; American Academy of Pediatrics. Pediatric emergency medicine fellow training in ultrasound: consensus educational guidelines. Acad Emerg Med. 2013 Mar;20(3):300-6. doi: 10.1111/acem.12087.
• Lam SH, Wise A, Yenter C. Emergency bedside ultrasound for the diagnosis of pediatric intussusception: a retrospective review. World J Emerg Med. 2014;5(4):255-8. doi: 10.5847/wjem.j.issn.1920-8642.2014.04.002.
• Riera A, Hsiao AL, Langhan ML, Goodman TR, Chen L. Diagnosis of intussusception by physician novice sonographers in the emergency department. Ann Emerg Med. 2012 Sep;60(3):264-8. doi: 10.1016/j.annemergmed.2012.02.007. Epub 2012 Mar 15.
• Bhisitkul DM, Listernick R, Shkolnik A, Donaldson JS, Henricks BD, Feinstein KA, Fernbach SK. Clinical application of ultrasonography in the diagnosis of intussusception. J Pediatr. 1992 Aug;121(2):182-6. doi: 10.1016/s0022-3476(05)81185-0.
• Verschelden P, Filiatrault D, Garel L, Grignon A, Perreault G, Boisvert J, Dubois J. Intussusception in children: reliability of US in diagnosis--a prospective study. Radiology. 1992 Sep;184(3):741-4. doi: 10.1148/radiology.184.3.1509059.
• Williams H. Imaging and intussusception. Arch Dis Child Educ Pract Ed. 2008 Feb;93(1):30-6. doi: 10.1136/adc.2007.134304. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Point-of-care ultrasound; Intussusception; Pediatric Emergency Medicine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Emergencies; Intussusception
• Other Study ID Numbers: 1711-153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes